EpiHeart - Enabling new cardiac treatments
The patient’s own cardiac tissue can be used in connection to surgery to support the healing of cardiac damage. New treatment methods enabled by medical devices create foundation for quick and profitable growth.
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The two key factors that led to the founding of EpiHeart Oy were the wish to develop new cardiac treatments that give the patients more life years and enhance their quality of life, and the wish to create a profitable and rapidly growing medical technology company that would enable these treatments to be used extensively. The treatment method that the company’s operations will be focused on in the initial phase has been researched and developed over a long period of time through academic research, especially at the University of Helsinki and the Helsinki University Hospital HUS. The results gained from the research and the first patients, as well as the results of the preceding trials, have been promising. The treatment is administered in connection to surgery and is based on the patient’s own cells. It has good prospects to become the first cellular or tissue therapy that is approved for extensive clinical use. The treatment can be implemented by using the medical equipment designed by EpiHeart for use in connection to cardiac surgery and optimised to be simple to use, which enables a quick entrance into the market. More generally, the company’s business idea is to become the leading supplier of medical devices that enable the surgical administration of various cellular and gene therapies in the cardiac surgery sector.
Cardiac Micrograft Therapy™ - A new method to treat cardiac damage caused by oxygen deficiency
Ischemic heart diseases and heart attacks often cause irreparable damage in the heart muscle. The damage is caused by blockages in the coronary artery, which result in a lack of oxygen in the heart. These blockages can be treated with drugs or through catheterization or stenting, or a vein can be taken from another part of the body to bypass the blockages in a coronary artery bypass graft (CABG) surgery. However, opening of the blockages does little to repair the tissue damage or the scarring of the heart muscle and the heart failure. Tissue damage and related effects cause a significant number of premature deaths and, even in milder cases, the impact on the quality of life is significant1,2. The need for more effective treatments is clear. A new treatment method known as Cardiac Micrograft Therapy™ has been developed to make the modern treatments more effective.
Cardiac Micrograft Therapy™ in short
The starting point of the developed treatment is to utilise the patient’s own cardiac tissue as a therapeutic graft, which can be done easily in connection to a CABG surgery. This approach is supported by the fact that, in practice, all patients approved for CABG surgery have some level of damage caused by a lack of oxygen in their heart muscle. A small sample of the patient’s cardiac tissue can be collected safely in connection to the surgery for the graft. In practice, this sample is removed from the atrial appendage, when the patient is connected to a cardiopulmonary bypass. This treatment method has been developed so that it is possible to process this tissue into small micrografts with a diameter of a few dozen or hundreds of micrometres. In other words, the tissue is broken down into smaller pieces so that the properties of the tissue are maintained whilst the surface area increases. These grafts are then cleaned and positioned on top of the damaged area in the heart muscle with the help of a commercially available cell-free connective tissue matrix (epicardial application). In other words, the graft is made from the patient’s own cardiac tissue during the same surgery by a trained operating room nurse. The treatment supplements the CABG surgery and has practically no impact on the duration or risks of the surgery. The additional work done by the surgeon consists of attaching the graft over the damaged area with three stitches.
The safety and effectiveness of the treatment – built on a long research history
The basic starting points of the treatment were established around ten years ago, when an optimal approach was being sought by the researchers of the University of Helsinki and the surgeons of Helsinki University Hospital from the points of view of, e.g., the experiences gained from stem cell therapies and the practical implementation of cardiac surgeries. This brainstorming and later research activities involved a number of people, some of whom became the founders of the present company and some of whom still work as the advisers of the company or independent researchers and cooperation partners. Once the idea had been formed, a lot of work remained to be done. Laboratory tests have been completed over the years, as well as animal tests on small and larger animals and, most recently, a first-in-human study on six patients. The results have been encouraging in every phase and, subsequently, the safety of the treatment has been well established. The results gained from both animals and people indicate that the treatment has positive impacts. In the studies, the impact is visible in the walls of the heart chambers (ventricular wall) , which have become stronger, in addition to which there are indications of a reduction in the volume of scar tissue and its replacement with healthy tissue.
In the first study implemented on people, six patients were treated. The same study was also implemented on a comparison group of an equal size. Differences were observed between the treated patients and the comparison group in the thickness of the chamber wall, for example, which is critical for heart failure: Thickening was observed in all treated patients, the average growth being around 1 mm. In the comparison group, one person died of heart failure before the six-month control appointment, two manifested no change, and in three patients, the thickness of the chamber reduced (on average, by around 1.5 mm). Therefore, there are clear indications of positive impacts on the patients, but more extensive research is necessary to prove the effectiveness of the treatment reliably. Some of the funds raised through this issue of shares will be used to implement the necessary patient studies as quickly as possible.
Animal models, in particular, have provided an understanding of the impact mechanisms of the treatment. Based on the research, micrografts remain healthy for a long period of time; at least for weeks or months. The micrografts also communicate with their environment through paracrine mechanisms. Based on the best available understanding, the mechanism of action is based on biological substances excreted by micrografts (e.g., growth factors and cytokines), which modulate infection reactions and the differentiation of cells. All in all, the results are promising, and developing the treatment towards extensive clinical use is clearly justified.
Some of the research results have been published in respected international peer-reviewed publication series. Pre-clinical results have been described in the article by Xie, et al.,3 and a case study has been published of the first patient (Lampinen et. al)4. The results of the first-in-human study have been submitted for publication and are currently in peer review.
The company is involved in close research cooperation. An agreement was made with the University of Helsinki and HUS especially on the utilisation of the existing research results and future cooperation in the form of a Memorandum of Understanding that was signed in early 2020. Cooperation has also been established with several European university hospitals.
The promise of a more healing CABG surgery opens up an enormous market potential
EpiHeart Oy was founded to develop and manufacture equipment that enables the new treatment. EpiHeart Oy’s value promise is, therefore, to enable Cardiac Micrograft Therapy™. The new treatment is expected to generate value not only to the treated patients but also to units specialising in cardiac surgery. The number of CABG surgeries has decreased in recent years, as cardiological methods implemented through the veins (angioplasty and stenting) have become more common. For a significant number of patients, a CABG surgery is, however, still the best option, and it remains a routine operation at university hospitals globally. As a value promise, an adjuvant therapy that involves few risks and requires little effort, but provides significant additional benefits to the patient, is significant for units specializing in cardiac surgery. The added value generated by the units and individuals, as well as the benefit to the patient, increases.
In 2018, a total of around 190,000 CABG surgeries were carried out in Europe (Source: Eurostat). The volume of surgeries is within the same range in the United States. Heart diseases are a major and increasing medical concern, also in other parts of the world. Observing various factors, such as the number of patients and preliminary discussions on the pricing, the market potential can be expected to be up to 1,000 million euros a year. Alternatively, the potential can be viewed in relation to the total cost of CABG surgeries, which is estimated to be around 14 billion euros globally (Grand View Research, 2019). Naturally, the realisation of this potential involves several questions. In the early stages, it is important to be able to prove the benefits and to start building the market one hospital at a time.
A direct route to the market
The company’s aim is to enter the market as directly and quickly as possible. The quick progress is facilitated by a product-oriented business model, the current development stage of its own products, cooperation with key suppliers, established cooperation with hospitals, and a good understanding of the regulatory environment.
Based on the company’s estimate, its overall solution will be ready for clinical trials by the mid-2021. The overall solution consists of the company’s own products, equipment customised for the needs of the company by its cooperation partners, and standard products found in the market. The company expects to be able to finish, within the same schedule, the testing and approvals in Europe that are needed to introduce the company’s own equipment and surgery kits assembled by it into the market. It should also be noted that the approvals required to introduce the products into the market are not an absolute requirement for clinical trials, even though they make matters more straightforward in many respects. Even though the sales can, from the legal point of view, be started already during 2021, more results are needed from clinical studies to support the sales. These results are expected to be gained during 2022, which will enable investments in the sales operations. In the sales operations, the company’s key goal is to make individual hospitals accept the treatment as a routine procedure, which would generate a continuous income flow.
It should be noted that in the sales operations, the clientele is easy to identify and networked. For example, there are five adult cardiac surgery units in Finland, whilst in Germany, the corresponding figure is 76. Therefore, reputation can be expected to spread from one unit to another. Research-orientation and the use of scientific evidence are typical of the field as regards decision-making. This is made easier, to a certain extent, by further clinical studies that are currently being prepared for and the option to sell equipment for research use in the initial phase when evidence is still being gathered of the benefits of the treatment. Even though the company focuses on the commercialisation of the above described Cardiac Micrograft Therapy™, it also actively monitors the research and commercial development of cellular and gene therapies more extensively and aims to establish cooperation relations with carefully chosen parties and to utilise commercial opportunities.
Why invest in EpiHeart?
The company has a feasible and straightforward plan to introduce into the market the equipment needed for the Cardiac Micrograft Therapy™ treatment, and to have this treatment, which uses the company’s own products, accepted as a generally used adjuvant therapy in CABG surgeries. With this development, the company will establish a position as a facilitator of cellular and gene therapies that are related to cardiac surgery and are administered by using medical devices. In the company’s view, it can grow into a profitable medical device company that is ready to be listed within a relatively quick schedule – on estimate, within three years. If we succeed in this, the natural consequence is a significant value generation to the owners.
Even though EpiHeart Oy has commercial goals as a company, it should be noted that the company also facilitates scientific research through its operations and aims to enable a better treatment of heart diseases.
The opportunities offered by the company in a nutshell:
- The company’s business operations enable new surgical cellular and gene therapies by means of medical devices.
- The first treatment to be enabled (Cardiac Micrograft Therapy™) has been developed over a long period of time – around ten years of academic research. The results gained from clinical studies have been promising. This provides a strong basis for straightforward progress.
- The potential of the target market is significant. An adjuvant therapy that creates benefits to the patient can be expected to expand the CABG market, when the treatment is taken into use. At the present time, the estimated global value of CABG surgeries is 14 billion euros a year (Grand View Research, 2019).
- The regulation strategic approach that avoids the application of the ATMP regulation (Regulation EC 1394/2007) and utilises some already approved medical devices as part of the overall solution delivered by the company enables a quick entrance into the market and reduces the capital needed by the company.
- The targeted clientele of the company can be reached through specialised distributors internationally.
- The cost and profit structures create conditions for the extensive use and excellent profitability of the treatment.
- The company can utilise research results, of which a cooperation agreement has also been signed with the University of Helsinki and HUS. The company aims to establish a sustainable competitive edge in many ways. For example, the company has two patent applications currently pending, and the company’s overall solution also involves business secrets.
- The funds raised through the current issue of the shares will be used to develop the company with the principal aim to 1) finish the development of the products and surgery kits that facilitate the administration of Cardiac Micrograft Therapy™ and 2) launch more extensive clinical trials by mid-2021. Product development involves proving the conformity of the devices with legislation (CE-marking). Some of the funds raised through the issue of the shares will be used to launch the sales operations. In 2021 and for most of 2022, the sales are expected to be mainly restricted to research sales and customer pilots. The aim is that the sales will start to increase rapidly from late 2022 onwards.
- Svenja Hinderer S., Schenke-Layland K., (2019) Cardiac fibrosis – A short review of causes and therapeutic strategies,Advanced Drug Delivery Reviews, https://doi.org/10.1016/j.addr.2019.05.011.
- Richardson, W. J., Clarke, S. A., Quinn, T. A., & Holmes, J. W. (2015). Physiological Implications of Myocardial Scar Structure. Comprehensive Physiology, 5(4), 1877–1909. doi:10.1002/cphy.c140067
- Xie, Y., Lampinen, M., Takala, J., Sikorski, V., Soliymani, R., Tarkia, M., ... Kankuri, E. (2020). Epicardial transplantation of atrial appendage micrograft patch salvages myocardium after infarction. Journal of Heart and Lung Transplantation, 39(7), 707-718
- Lampinen et.al. Intraoperative processing and epicardial transplantation of autologous atrial tissue for Cardiac repair; J Heart Lung Transplant. 2017 Sep;36(9):1020-1022. doi: 10.1016/j.healun.2017.06.002.
Our business & market situation
Product and demand
The company’s products are divided into operating room equipment and a one-per-procedure surgery kit. In other words, certain equipment must be acquired into the surgery room as a one-off procurement to be able to provide the therapy. In addition, a surgery kit by EpiHeart Oy is needed for each individual patient. These two categories constitute EpiHeart Oy’s sales. EpiHeart also offers instructions and training related to the therapy itself and to related third-party products that are included in the normal equipment of surgery rooms and are not sold by the company.
The main equipment sold by EpiHeart Oy to surgery rooms are the EpiHeart ORC-40 Operating Room Centrifuge and the EpiHeart CP-42 Cooling Plate. These devices have been designed by the company for use in surgery rooms and enable measures required to complete cellular therapy. The devices are not technically challenging to operate, but similar equipment is not currently typically found in surgery rooms. In addition, a number of special requirements have been observed in the design of the devices related, for example, to sterility, usability in the surgery room environment, and the electric safety regulations applied to medical devices.
The patient-specific surgery kit contains the single-use products that are needed to implement the therapy. In addition, a set of regulations contained in European legislation (especially Article 22 of the MDR regulation) is applied to the surgery kit as regards its compatibility and other aspects of the products. EpiHeart is responsible for the entire surgery kit and is also the manufacturer of some of the products included in the kit, which are not separately available in the market. The current version includes four such products. The surgery kit contains products for the processing of tissue, making and cleaning of micrografts, and making of the transplant. The current surgery kit version includes 20 individual products. For the most part, these are relatively simple, but the aspects to be observed in individual products and their mutual compatibility are numerous.
The significance of regulation for business operations
Unlike with most advanced cellular therapies, introducing Cardiac Micrograft Therapy™ into the market is not extremely difficult and time-consuming. In this treatment, the patient’s own cardiac tissue is used to implement the therapy and the cells are not manipulated in a way that would require the provisions of the ATMP regulation (Advanced Therapeutic Medicinal Products, EC 1394/2007) to be applied to the products or the treatment. This interpretation of the company has also been confirmed in discussions conducted with the supervisory authority (FIMEA). No discussions have, as yet, been conducted with American authorities, but based on the completed surveys, the requirements of the corresponding American HCT/P regulation do not need to be observed. This is due to the derogation (21 CFR 1271.15(b)) concerning treatments that are implemented during the same surgery.
In addition to a quick entrance into the market, the new treatment also has significantly lower unit costs than typical cellular therapies. When the cells of the patient do not need to be cultivated outside the body, there is no need to transport or process the cells in accordance with the good manufacturing practices required from pharmaceutical producers.
EpiHeart Oy enables the treatment with equipment. The equipment is subject to normal legislation on medical devices and other product legislation both in Europe and elsewhere in the world. European regulation is shifting from the era of the old Medical Devices Directive (MDD) to the era of the new Medical Devices Regulation (MDR). In the United States, the regulation is supervised by the Food and Drug Administration FDA. In addition to the actual requirements applied to the products, the requirements of the aforementioned European medical devices legislation are applied to the surgery kits. EpiHeart develops and manufactures the medical devices in accordance with the required processes and in compliance with the ISO 13485:2016 standard. The company has also adopted, as its practice, to develop the surgery kits in accordance with the medical device development process, which ensures their quality and compliance with regulations. EpiHeart expects to finish the necessary tests and approvals for the said products during 2021; the goal is the mid-2021.
The company’s operating model is to enable the new treatment with the dedicated and proprietary medical devices that the company sells. The company also provides instructions and training, and organises scientific research on the safety and effectiveness of the treatment. The sales are, principally, implemented through specialised local distributors, who already sell other products to units specialising in cardiac surgery. The sales consist of equipment needed in the surgery room (a one-off procurement) and patient-specific surgery kits (a regular source of income).
The treatment developed by the company requires various medical devices, and also the compatibility of these devices needs to be ensured. The company’s approach is that it ensures and is responsible for the compatibility of these devices, and owns the overall solution. On the other hand, the company has a strategic approach to individual devices. The company manufactures some of the products, whilst some other products can just be purchased on the market. The company also aims to establish strategic partnerships on certain products, and also conducts its own research and development activities at the same time. Such strategic partnerships especially apply to the areas of micrograft rasps and cell-free connective tissue matrixes. In these product areas, there is a limited number of manufacturers and products with the necessary approvals in the market.
The use of already approved third-party medical devices enables a significantly quicker entrance into the market than if everything was to be developed independently. The difference is easily several years and millions or even tens of millions of euros. The management of the company understands that third-party products involve numerous questions (such as bargaining power, quality, and profit structure), but these challenges can be addressed by maintaining our own research and development activities at a sufficient level and by acting in a strategic and deliberate manner. Overall, this approach provides a number of realisation options (own products, co-companies, company acquisitions).
Pricing is a key factor in the company’s business model. It is the company’s understanding that the price as per each patient can easily be set at a level that enables good profit margins, whilst also enabling making Cardiac Micrograft Therapy™ a routine element of CABG surgeries. This is important, because if the therapy is statistically beneficial and also easy to implement and reasonably priced, the hospital does not need to carry out patient-specific examinations to determine the situation of each individual patient, but the therapy can be implemented as a routine procedure. Naturally, the treatment can, in the initial stage, only be a standard procedure in certain segments, such as acute CABG surgeries. Another reason why a cost-effective solution can be expected to quicken the opening of the market is compensation practices. In several countries, hospitals receive their funding from various types of insurance and procedure-specific payments. A reasonable price enables university hospitals to “do what they need to do” within the valid compensation practices and budgets. Compensation codes may need to be applied for in several countries, but business operations can be started before they have been issued. Based on completed negotiations, the price of the patient-specific surgery kit could be around a few thousand euros.
Sales, production, and distribution
The users and customers of the company’s products are the units specialising in cardiac surgery first in Europe and later globally. The company’s operating model is based on generating demand through science, publications, conferences in the sector, and network impacts. The sales are, principally, implemented through specialised local distributors, who already sell products to units specialising in cardiac surgery. Even though the products are not complex, a certain local support and understanding of local budgeting and purchase practices are needed. The business operations are being supported by the fact that both the customers and possible distributors are easy to identify. The sales are repetitive and the scale of the purchases made by individual customers is large, which enables taking good care of the customers (e.g. trainings).
The company also utilises sub-contracting in the manufacture of its own products and surgery kits, even though it bears the manufacturer’s responsibility as regards these products. The company has chosen most of its key sub-contractors, even though formal contracts have not yet been signed in most cases. The company also has its own operations related to manufacturing. For the most part, the operations related to manufacturing focus on measures concerning the management of sub-contractors and quality assurance. In addition, at least some assembly work related to the equipment and the surgery kits will be implemented in the initial phase in addition to internal management of the end product warehouse, whilst seeking for suitable cooperation partners.
The treatment of ischemic cardiac damage and heart failure are widely recognised problems, for which better treatment methods have been and are constantly being sought. At the present time, heart failure is, principally, treated by ACE inhibitors that lower the blood pressure, beta blockers that lower the pulse, and diuretics. In some cases, a booster pump or a heart transplant may be needed, both of which are very expensive procedures. Several different kinds of new medicines and other treatments are also currently in the research phase, but there is no single competitor that could be considered a threat. No similar treatment has been developed elsewhere, and the problem is not going to go away either. To the contrary, the backlog caused by Covid-19 and the repercussions of the infection are expected to increase the demand significantly.
If the results gained of Cardiac Micrograft Therapy™ in larger-scale studies are in line with the research results gained up until now, all criteria for the spreading of the treatment method will be met. The competition position of the company in the light of current practices is strengthened by the relatively reasonable additional cost to the total cost of the CABG surgery and the small-scale of the effort needed and the risks involved from the point of view of the unit that carries out the procedure. It is natural to administer any appropriate adjuvant therapies that support the long-term wellbeing of the patient in connection to a large operation.
Sustainable competitive advantage
The company’s products cannot easily be copied by competitors. This solution is based not only on individual products but also the entity formed by different products, and the impact of this entity on the treatment process and the result of the treatment.
The company currently has two patent applications pending and one more is being prepared. Whilst these patents protect the company’s business operations to a certain extent, non-patentable information collected through research, clinical trials, and customer feedback also contribute to the sustainable competitive advantage.
The company aims to protect itself against competition through relatively traditional and multiple means. This means that the company aims to create and maintain a good reputation, keep certain matters confidential, and act in a cost-efficient manner. The company does not need to make any major investments that would deteriorate its profitability, should any competition arise.
It is the aim of the company to enter the market as directly as possible. The size of the market is, as such, sufficient. It is key to finish the products, gain more results from clinical studies, and initiate growth. In the growth, it is key to find active users among hospitals, as every active hospital will generate hundreds of thousands of euros’ worth of turnover on an annual basis.
The company understands the importance of focusing and aims to focus on the direct growth path described in the above. However, the company’s business operations concern products related to surgical cellular therapies, and the next alternative or supplementary growth paths are being considered actively. The company can be expected to allocate some of its resources to preparing the selected paths and, based on consideration, also to progressing these paths. Some of the possible paths have been described below.
- Extending sales operations to the United States. The United States offers significant opportunities thanks to its large market, in addition to which the equipment class of certain key devices is lower in the United States than in Europe. The aim is to enter the European market first, but if a suitable operating model is found through cooperation partners, for example, the entrance to other markets can happen sooner.
- mRNA / gene therapies. The impact mechanism of the developed micrograft therapy is understood to be based on the fact that transplanted cells send signals through natural mechanisms and modulate inflammatory reactions, for example. Various medicines and gene therapies are also being researched around the world that would enable similar effects. One approach is to utilise mRNA and plasmid DNA as messengers in the therapies. Major companies, such as Moderna and AstraZeneca, carry out research in this area. The expertise, equipment, and development activities of EpiHeart Oy have the potential to support the dosing of such medicines into the heart. As an actual growth path, this is further away in the future, but the company plans to examine research cooperation opportunities during 2021. The actual research work would, however, be principally completed with the help of research funding from cooperation partners or the EU. As a concrete measure, the intent is to build a suitable research consortium and to apply for Horizon Europe funding for “Next generation advanced therapies to treat prevalent and high burden diseases with unmet needs”. The call for projects within the programme is expected to be announced during 2021.
- Percutaneous therapy. If the clinical results of the treatment are as expected, it may be justified to investigate methods to administer the therapy without open-heart surgery. Various laparoscopic and percutaneous surgeries implemented through small incisions that cut through the skin have become more common, but developing this kind of treatment and the equipment needed by it is a large-scale project. For this reason, an open-heart surgery approach is considered, for the time being, to be optimal, but the matter is being considered.
- Cellular therapy equipment generally. The company’s equipment enables cellular therapy in the surgery room. Even though the focus is on the Cardiac Micrograft Therapy™ treatment, the market is being monitored in general.
CEO and Founder
MSc in Engineering (Industrial Engineering and Management) with long and extensive experience of various tasks in high-technology companies. This experience includes over ten years of experience in the founding and extending of health and medical device companies in a managerial position.https://www.linkedin.com/in/kai-kronstr%C3%B6m-5b33b/
Head of Science and Founder
MD in Medicine with long experience as a researcher of various regenerative treatments, including cellular therapies. Kankuri has for a long time worked for the University of Helsinki, where he has been responsible for research on the regenerative treatments of the heart at the Faculty of Medicine, Department of Pharmacology.
Design Engineer and Partner
Student of technology with solid experience in product development projects.
Licentiate of medicine and cardiac surgeon, whose dissertation addresses the said treatment method.
Partner and Member of the Board, Advisor especially in quality and regulatory matters
DSc (Technology) with expertise in medical device regulation and in the development of new cardiological devices.
PhD in medicine and surgery. Professor (emeritus) in cardio-thoracic surgery.
MSc (Economics and Business Administration) with long experience in the sale of medical devices (e.g., Baxter).
PhD in biochemistry Rodosthenous has researched heart regeneration at Harvard and Mass. General Hospital.
MSc (Economics and Business Administration) with long experience in the sale of medical devices and in entrepreneurship.
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Attached to the pitch there is a creditworthiness report that may be relevant for the investment decision
The company’s operations naturally involve risks. The most significant risks and the company’s views on them are described below.
The company operates in a highly regulated sector and understands the significance of regulation. The company recognises the product-specific requirements of the regulation in the product development process and has discussed regulation matters with the authorities. This does not mean that surprises cannot occur as regards the interpretation of regulations or unidentified regulations, in addition to which any future changes made to the applicable regulations can place new kinds of requirements or require additional measures. The company also uses products manufactured by other companies and subcontractors, which are also subject to similar regulations and, therefore, the same risks related to the identification and application of applicable regulations and measures required by possible changes to these regulations apply to them. Therefore, risks related to regulations can also be realised through the availability of subcontractors or products.
The company employs only a small number of people and their expertise is critical. The company has committed all the key persons to the company through ownership, and the conditions for the development and growth of the team are good. Various types of personnel risks, such as recruitment difficulties or situations where the key persons are no longer available to the company, are always risks.
The company has no special identified legal risks or pending disputes. The realisation of legal risks is, however, always possible, even though the risks are minimised through normal good management practices and carefully considered agreements.
Risks related to predicting the future
The company’s business plan is based on several assumptions of the future, including assumptions of the operations and the operating environment of its customers, cooperation partners, and other parties, and of the development of the company’s financial situation. Creating a new growth company requires a certain amount of optimism, but, based on the understanding of the company’s management, it is being very realistic. However, predicting the future and assumptions always involve risks and uncertainties.
Risks generated by additional funding needs
The company may require additional funding, but the funding of the company and the availability of the necessary funding are not something to be taken for granted in all situations. If the company succeeds at achieving its goals reasonably well, it can be expected to be an interesting subject of investment, meaning that the preconditions for the funding of the development and growth of the company in various situations will also be more diverse.
The plans cannot be implemented as expected
The company is relatively confident as regards the implementation of its plans, but delays caused by internal or external factors or other hindrances cannot be completely ruled out.
Patient safety is always a relevant threat for a medical device company. Patient safety is also a significant concern for the company’s management. It is good news that, based on the completed studies, the company’s products do bring significant benefits to the patients and the safety profile of the therapy is excellent. The company develops, manufactures, and monitors its products in accordance with the regulations and best practices in the field. Risk management will be implemented in a manner instructed in the European regulation on medical devices and the ISO 14971 standard (Medical devices. Application of risk management to medical devices).
The results of the upcoming clinical studies are not in line with the results achieved so far
The most significant risk of the company is that the results gained from future clinical studies are, ultimately, not in line with the previous results. This is a genuine risk, but if this risk would be likely, we would never have founded the company nor put effort in it. Should this risk be realised against the expectations, turning the course of the company would need to be considered. In such a case, decisions would be made based on the best available information; however, some alternatives have been presented in the growth paths section.
Starting of sales operations is delayed
The starting of the sales operations can be delayed for various reasons, and various risks are related to product development, product approval, clinical trials, and the delivery chain. As regards the value creation of the company, it should be noted that the funding raised in this round, should the funding round be successful, would enable the reaching of several landmarks that generate added value, such as manufacturing products for clinical trials and launching more extensive clinical trials. It should also be noted that the risk classification of the company’s own products, which are needed as part of the overall solution, is such that their introduction into the market can be implemented in a relatively risk-free manner during spring 2021.
The sales grow slower than expected
The sales often grow slowly at the beginning, even when they are to accelerate later. This is a realistic risk that must be accepted. In practice, the company aims to continuously get a feel of the market and to recognize the reasons that slow down the sales and prevent the quick increase in the sales. One such reason is the scantiness of clinical evidence. However, no “excessive” investments will be made in the sales before the dynamics of the sales are understood and heavy investments in the sales operations are considered to be justified.